Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
IGA MZ CR NS 10368-3
Study information
Scientific title
Randomised, open-label study comparing the efficacy of antidepressant monotherapy and antidepressant combinations in the acute treatment of patients with resistant depression
Acronym
D-REZ-KOMB
Study hypothesis
The aim of our study is to examine efficacy of antidepressant monotherapy and combinations of antidepressants in the treatment of resistant depression in common clinical practice. We will test the following null hypotheses:
1. That the reduction of depressive symptoms does not differ between monotherapy and combinations groups
2. The number of responders in both groups does not differ
Ethics approval
The Ethics Committee of Prague Psychiatric Centre approved on the 21st May 2008
Study design
Single centre two arm open label randomised active controlled parallel group trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Not specified
Trial type
Treatment
Patient information sheet
Not available in web format, please use contact details below to request a patient information sheet
Condition
Resistant depressive disorder
Intervention
Patients will be randomly allocated to antidepressant monotherapy group or combination of antidepressant group. Specific antidepressant will be chosen by attending psychiatrist according to clinical judgment and with regard to the history of previous treatment. Antidepressant or combinations of antidepressant will be used in the dose cited in Summary of Products. Both interventions are defined as a new intervention not augmentation of previous antidepressant treatments. We will administer combinations that are commonly used in clinical practice. The total duration of treatment is 6 weeks. We will evaluate stability of outcome in responders after 2 months.
Intervention type
Other
Phase
Not Applicable
Drug names
Primary outcome measures
The change in the Montgomery-Asberg Depression Rating Scale (MADRS). Patients will be rated at baseline, week 2 week 4 and the end of acute treatment and responders after 2 month of treatment.
Secondary outcome measures
Response to treatment that is defined as a greater than or equal to 50% reduction of MADRS score from baseline to the end of treatment.
Overall trial start date
01/01/2009
Overall trial end date
30/06/2011
Reason abandoned
Eligibility
Participant inclusion criteria
1. Patients suffering from major depressive disorder (recurrent or single episode) diagnosed according to Diagnostic and Statistical Manual of Mental Disorders, 4th Edition (DSM IV) criteria, confirmed using the Mini-International Neuropsychiatric Interview (MINI) Czech version 5.0.0.
2. Patients fulfilling at least Stage I criteria for resistant depression according to Thase and Rush, 1997
3. The mental ability to understand and sign Informed Consent Form
4. The score in Montgomery-Asberg Depression Rating Scale greater than or equal to 25 and the score in Clinical Global Impression greater than or equal to 4
5. Outpatients and inpatients
6. Age between 18 and 65 years
Participant type
Patient
Age group
Adult
Gender
Both
Target number of participants
60 participants
Participant exclusion criteria
1. Contraindications of used antidepressant treatments according to Summary of product (SPC)
2. The use of antidepressants as a monotherapy or as a part of combination that were ineffective in the treatment of current episode
3. The use of antipsychotics, thymostabilizers and other biological treatment of depression (ECT, rTMS, sleep deprivation etc.) during the study (anxiolytics and hypnotics for case of severe anxiety and insomnia are permitted) as well as formal psychotherapy
4. Comorbidity of Axis I and II (DSM IV) disorders in the 6 month before enrollment to the study
5. Severe or uncontrolled somatic disorders, likely to cause depressive symptoms or interfere with the conduct of the study
Recruitment start date
01/01/2009
Recruitment end date
30/06/2011
Locations
Countries of recruitment
Czech Republic
Trial participating centre
Prague Psychiatric Center
Prague 8-Bohnice
181 03
Czech Republic
Sponsor information
Organisation
Ministry of Health (Czech Republic) - Internal Grant Agency
Sponsor details
Palackeho nam.4
Prague 2
128 01
Czech Republic
Sponsor type
Government
Website
Funders
Funder type
Government
Funder name
Ministry of Health (Czech Republic) - Internal Grant Agency (ref: No. NS 10368-3)
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Participant level data
Not provided at time of registration
Results - basic reporting
Publication summary